Karla Fernandez Email & Phone Number

San Diego County, California, United States

• Coordinated and facilitated completion of milestones and deliverables for projects under direction of Core Team Leader.
• Supported design reviews by tracking deliverables, reviewing information, and communicating status completion to core team leaders and team members. Ensured action items were resolved and documented in a timely manner.
• Maintained design control database supporting Product Requirement Document, Product Specification Document, Risk, and other trace matrix data.
• Processed and maintained design control documentation and Design History Files per standard operating procedures.
• Communicated with cross functional stakeholders to ensure project/program success.

San Diego, California

• Supported On-Market Support, Operations, and Packaging teams to design and manufacture the FDA Emergency Use Authorization of a SARS-CoV-2 molecular diagnostic test.
• Designed, planned, and executed experiments for robust detection of viral gastrointestinal diseases on the Panther Fusion platform.
• Executed thorough analysis utilizing JMP and Excel to summarize and interpret data.
• Presented analysis on weekly group meetings and collaborated with planning/leading follow up experiments with Scientists, Managers, and Director.

San Diego, California, United States

• Leader for 2-10 members in manufacturing of the Panther Fusion SARS-CoV-2 Diagnostic Test.
• Operated automated synthesis and purification instruments to produce DNA, RNA, and modified oligonucleotides following detailed SOPs in a GMP environment.
• Continuously reviewed controlled documents for quality assurance and completed manufacturing documentation according to strict GDP guidelines.
• Maintained accurate and detailed material inventory using Oracle for tracking lots used during manufacturing and for accurate financial tracking.

Los Alamitos, California, United States

• Operated chemical, biological, radiological, nuclear (CBRN) detection equipment, and conducted CBRN sampling/monitoring operations to identify chemical and physical effects/characteristics of hazardous materials.
• Performed assigned missions/tasks and response operations at the HAZMAT technician level.
• Identified principles and performed methods of mass casualty decontamination procedures and performed site security operations.

San Diego, California

• Two-month interim Supervisor responsible for maintaining lab productivity. Utilized JIRA software to track timelines and coordinated completion of deliverables by managing daily schedules for 10-15 lab members.
• Performed routine testing on the Continuous Glucose Monitoring (CGM) System following detailed SOPs, MPIs, and chemical safety guidelines to ensure compliance with GLP and cGMP standards in an FDA regulated environment.
• Collaborated with Scientists/Engineers in troubleshooting, designing, and improving efficiency of experiments. Worked closely with Document Control, Quality, Operation, and various additional teams to write.
• Utilized MATLAB, JMP, and Excel to analyze, interpret, and present data, and to update databases with historical data.
• Assumed responsibility for ensuring equipment Calibration, Preventative Maintenance, Material Identification & Segregation, and Good Documentation Practices.

Greater San Diego Area

• Performed routine testing on different components of the Continuous Glucose Monitoring (CGM) System in a timely manner while ensuring prompt delivery, and maintaining a safe and cost efficient environment
• Performed experiments following detailed SOPs, manufacturing process instructions, and chemical safety guidelines to ensure compliance with GLP and cGMP standards in an FDA regulated environment
• Processed data, analyzed, and discussed results/observations with Research Associates and Supervisor
• Maintained constant verbal and written communication with test requestors, supervisor, and lab members to ensure efficient completion of tests

Greater San Diego Area

• Constantly communicated with supervisor to prioritize assignments, maintain workflow, and work productively in meeting deadlines of large scale library development and improvement projects
• Followed detailed oral and written instructions and properly documented completed tasks daily
• Maintained proper and organized inventory of materials and equipment
• Trained new hires to increase work productivity and improve competency of student workers
• Worked independently and in teams of up to 15 persons under minimal supervision

Spencer Lab

• Used CRISPR/Cas9 to mediate a deletion of exons and restore the reading frame of the dystrophin gene in Duchenne muscular dystrophy mice models
• Performed BLAST alignment on human DNA sections with animal DNA to design gRNAs conserved for large animal model testing
• Collaborated with graduate student in designing gRNAs and cloned guides into cell plasmid for CRISPR/Cas9 mediated deletion of exons in the dystrophin gene
• Cryosectioned and stained mice skeletal muscles with antibodies, and hematoxylin and eosin (H&E)
• Quantified experimental data through quantitative analysis of gRNA PCR surveyor assay
• Worked alone and under supervision of graduate student and postdoctoral researchers

Collins Lab

• Performed whole-mount in situ hybridization on Dugesia japonica for localization of acetylcholinesterase
• Performed RNAi knockdown of acetylcholinesterase in D. japonica to determine role in neurodevelopment
• Fed and cleaned animal containers according to schedules and feeding instructions
• Collaborated with graduate student on thesis project experiments
• Exhibited initiative and desire to learn new techniques and take on new responsibilities

Master Of Business Administration - Mba

Bachelor’S Degree, Biochemistry And Cell Biology

Activities and Societies: UC LEADS, Summer Bridge, 2Excel